Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Application - 2021

[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Page 41517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16337]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-877]

Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.


SUMMARY: AMRI Rensselaer, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before October 1, 2021. Such persons may also file a written request for a hearing on the application on or before October 1, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on May 31, 2021, AMRI Rensselaer Inc., 33 Riverside Avenue, Rensselaer, New York 12144-2951, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

Controlled Substance Drug Code Schedule
Marihuana 7360 I
Tetrahydrocannabinols 7370 I
Amphetamine 1100 II
Lisdexamfetamine 1205 II
Pentobarbital 2270 II
ANPP (4-Anilino-Nphenethyl-4-piperidine) 8333 II
Codeine 9050 II
Oxycodone 9143 II
Hydromorphone 9150 II
Hydrocodone 9193 II
Morphine 9300 II
Fentanyl 9801 II

The company plans to manufacture the above controlled substances as bulk active pharmaceutical ingredients (API) for use in product development and for distribution to its customers. In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2021-16337 Filed 7-30-21; 8:45 am]

BILLING CODE P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

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